Krill Oil safety

• Safety Profile of Omega-3 Fatty Acids
• Safety Profile of Krill Oil
• Astaxanthin & Canthaxanthin Levels
• References

Safety Profile of Omega-3 Fatty Acids

Adverse Effects

A recent review on the safety of omega 3 fatty acids by the US Food and Drug Administration concluded that a daily intake of EPA and DHA of up to 3 g is "generally recognized as safe^"1. Dosages as high as 3 g to 8 g of omega 3 fatty acids per day (10 g to 27 g fish oil) show virtually no significant adverse effects². The most common side effects observed with fish oil capsule consumption are complaints of a fishy taste and belching of fish flavours. At relatively higher doses, as with any oil, gastrointestinal complaints including loose stools have been reported.

 

Bleeding

Increased bleeding times that are within the normal range have been reported with very high intake of omega 3 fatty acids (ie, 7 g to 10 g omega-3 per day in Greenland Eskimos), but this side effect is regarded as posing little threat with supplemental doses under 5 g of omega 3 as EPA and DHA per day or the equivalent of ~15 g of fish oil ^3,4. However, owing to a lack of data and because some individuals may be at potential risk of increased bleeding from dosages of EPA and DHA of greater than 3 g/day, the FDA concluded that only intake levels limited to 3 g/day are “generally recognized as safe1.

Although there has never been a reported case of clinical bleeding attributed to fish oil consumption even during surgery, obvious consideration should be given to patients with bleeding disorders and patients taking blood thinners or anticoagulants ^3,4,5. In a prospective, randomized, controlled trial of a fish oil concentrate (32% DHA, 51% EPA, and 3.7 mg vitamin E/g) in 511 patients undergoing coronary bypass surgery, a dosage of 4 g/day for 9 months failed to cause any episodes of excess bleeding compared to the control group not receiving the fish oil, whether or not patients received 300 mg/day aspirin or warfarin sufficient to maintain an INR of 2.5-4.2 ⁶.

 

Dietary Recommendations

Currently, no formal governmental recommendations exist for dietary omega 3 fatty acid intake in the United States, unlike other developed countries such as Canada 7. Present US recommendations are to consume from 7% to 10% of energy as PUFA and for LA, a minimum of 1% to 2% energy. Despite the lack of governmental recommendations, a group of leading US physicians, biochemists, and nutritionists have released guidelines for adequate intake of omega 3 fatty acids 8. The proposed adequate intake for EPA and DHA is 650 mg per day (combined) with an LNA intake of 2.2 g per day. It has also been recommended that the intake of LA be limited to 6.7 g per day from the present average intake of 10-20 g per day. This recommendation, in effect, serves to reduce the average dietary LA to LNA ratio from the present 10:1 to 2.3:1. This would support greater conversion of LNA into long-chain omega 3, which is inhibited by elevated intakes of LA and high ratios of LA to LNA.

Canada and the United Kingdom, have established recommended daily intakes for omega 3 fatty acids 7. Canada recommends consumption of 1.2 g to 1.6 g omega 3 per day, although the guidelines do not specify which omega 3 should be consumed. The United Kingdom recommends LNA consumption be 1% of energy and EPA and DHA should comprise 0.5% energy which, based on a 2000 calorie diet, equates to 2.2 g of LNA and 1.1 g of EPA and DHA per day.

The American Heart Association (AHA) has recently recommended increasing the consumption of long-chain omega 3 for the prevention of primary and secondary heart disease ^9,10. For primary prevention, AHA recommends eating at least two fatty fish meals per week, a dosage approximately equivalent to 300 mg EPA and DHA per day. For secondary prevention, “consumption of one fatty fish meal per day (or alternatively, a fish oil supplement) could result in an omega 3 fatty acid intake (ie, EPA and DHA) of ~900 mg/d, an amount shown to beneficially affect coronary heart disease mortality rates in patients with coronary artery disease" ^9,10. The consensus of this report recognizes that while some positive data regarding consumption of dietary sources of LNA exist, primary benefit is achieved from dietary sources of the long-chain omega 3 fatty acids EPA and DHA in the prevention of primary and secondary heart disease.

 

Safe Dosages

Typical supplemental fish oil doses in the range of 1 g to 15 g per day (0.3 to 5 g EPA and DHA) are considered safe, while therapeutic doses of 15 g or greater should be taken only with the approval of a healthcare professional ^3,4,5.

 

 

Krill Oil Safety Assessment

Animal studies:

Long-term safety has been evaluated with a 6-month animal study.

Animal model: nude mice

Dosage: 16.6% daily diet or 3g per 21.94cm2 mean body surface

Human equivalent: 9 grams of EPA and DHA per day (70 kg person) which corresponds to 23.1 grams of oil or 7 – 11 times the recommended dose.

Duration: 6 months

Clinical observations: No adverse effects reported

Pathology results: autopsies performed on all systems revealed no pathological findings. The following organs were examined:

• Brain
• Lungs
• Heart
• Stomach
• Pancreas
• Liver
• Kidneys
• Uterus / prostate
• Intestine
• Skin

Human studies:

The results of the present toxicity assessment confirm that Krill Oil (KO) can be considered as safe for human consumption even at 2 to 3 times the highest recommended dose.

Note: People with a known allergy to fish or seafood were not tested in this study. The precaution remains that in the case of the above allergies, previous professional allergy testing is advised prior to consumption of Krill Oil (KO).

 

Laboratory Safety Analysis

 

REFERENCE METHOD: Digestion by nitric acid and hydrogen peroxide followed by ICP-MS (Inductively Coupled Plasma Mass Spectrometry)

HEAVY METALS	MDL	#02-6850	#02-6304	#02-6043
Lead μg/g	0.001	0.008	0.009	0.011
Cadmium μg/g	0.001	ND	0.002	ND
Mercury μg/g	0.001	0.001	0.001	0.002
Iron μg/g	0.01	3.01	3.14	3.02
Copper μg/g	0.01	0.24	0.21	0.29
Zinc μg/g	0.01	5.34	4.96	5.22

REFERENCE METHOD: Solvent residue, Mod. USP (gas chromatography)

ORGANIC SOLVENTS	MDL	#02-6850	#02-6304	#02-6043
Acetone % w/w	0.01	0.01	0.01	0.02
Ethyl acetate % w/w	0.01	0.01	0.02	0.02
Methanol % w/w	0.01	0.1	0.08	0.09
Ethanol % w/w	0.01	0.01	0.01	0.02

ORGANIC CONTAMINANTS	REFERENCE METHOD	MDL	#02-6850	#02-6304	#02-6043
PCB	In-House draft R7903	0.01	ND	ND	ND
Organochlorine Pesticides	In-House draft R7904	0.01	ND	ND	ND

OTHER	REFERENCE METHOD	MDL	#02-6850	#02-6304	#02-6043
Sulfite Residues, %	In-House draft R281	0.01	ND	ND	ND
Oxidative Degradation Products, %	In-House draft R7902	0.01	ND	ND	ND
Iodine Value, %	Mod. AOCS Cd 1d-92	0.3	136.4	134.9	135.1
Saponification Index mg KOH/g	Mod. AOCS Cd 3-25	1	173	168	164
Peroxide Value, meq/kg	Mod. AOCS Cd 8b-90	0.02	1.1	1.5	1.3
Microbial count			No growth 2 days (<1 colony-forming unit per ml)	No growth 2 days (<1 colony-forming unit per ml)	No growth 2 days (<1 colony forming unit per ml)

MDL – minimum detectable level

ND – not detected at minimum detectable level

Astaxanthin & Canthaxanthin Levels

The maximum dose of KO is 3g/day

Maximum allowable levels: